Objective: Preliminary study on the clinical efficacy and safety of modified Simiao San in the treatment of children’s purpura nephritis(isolated hematuria)with Shaoyin Damp-Heat.Methods: From December 2019 to December 2020,80 children with purpura nephritis(isolated hematuria)with Shaoyin Damp-Heat in children aged 3-18 who were in the pediatric clinic of Sichuan Traditional Chinese Medicine Hospital were selected and met the inclusion criteria.By SPSS random number method,they were divided into the experimental group(40 cases)and the control group(40 cases)according to the ratio of 1:1.The experimental group was given modified Simiao San orally,and the control group was treated with Tripterygium Glycoside tablets orally.Observing for 8 weeks,urine erythrocyte counts,urine latent blood and TCM syndrome scores were collected before treating and after 4 and 8 weeks of treating.SPSS26.0 was used to analyze the data to preliminarily observe the efficacy and safety of this experiment.One follow-up was performed 3 months after the end of the observation period.Results:(1)A total of 80 children with purpura nephritis(solitary hematuria)who met the criteria were included in this project.One case fell off in the experimental group and 2 cases fell off in the control group.A total of 77 cases were actually completed.There were 43 males and 34 females.The baseline data of the two groups were comparable(P>0.05).(2)There was no significant difference between the two groups in the comprehensive efficacy of the disease(urine erythrocyte count and urine latent blood)(P>0.05).The TCM syndrome curative effect of the experimental group was better than the control group(P<0.05).(3)There was no significant difference in the improvement ofurine erythrocyte counts and urine latent blood for 4weeks after treatment(P<0.05);the improvement of TCM syndrome scores in the experimental group was better than that in the control group(P<0.05).After 8 weeks of treatment,the experimental group was better than the control group in improvingurine erythrocyte counts,urine latent blood and TCM syndrome scores(P<0.05).(4)After 4 weeks of treatment,there was no abnormality in liver and renal function and blood routine of the children in the experimental group.One patient in the control group had a slight decrease in blood leucocytes and was given a drug reduction.The results returned to normal after one week.After 8 weeks,the liver and renal function and blood routine of the two groups were re-examined.There was no abnormality in the experimental group.3 cases of alanine aminotransferase in the control group were slightly elevated.After the drug was reduced for one week,the re-examination results returned to normal.Conclusion:(1)Both treatments were effective in the treatment of children with purpura nephritis(isolated hematuria),but there was no significant difference in the improvement of urine erythrocyte counts and urine latent blood.The curative effect of TCM syndromes in the experimental group was better than that in the control group.(2)There were no serious adverse reactions in the experimental group,and the clinical application was safe.Modified Simiao San in the treatment of children’s purpura nephritis(isolated hematuria)with Shaoyin Damp-Heat was worthy of reference and further studies. |